Latest news with #FederalFood
Epoch Times
15-05-2025
- Health
- Epoch Times
FDA Says It Might Change Infant Formula Requirements
The Food and Drug Administration (FDA) may change its nutrient requirements for infant formula, including floating the possibility of adding new mandated nutrients, the agency said on May 13. The agency started a review of the nutrients that are currently in formula, in what regulators described as the first comprehensive review since 1998. Through a People have until the end of Sept. 11 to respond. 'You can't Make America Healthy Again if we don't fix what nourishes our youngest and most vulnerable Americans,' Health Secretary Robert F. Kennedy Jr. Dr. Marty Makary, the FDA's commissioner, added: 'Protecting our most vulnerable is not just a moral duty—it is our responsibility. For many children, infant formula is their only source of nutrition. That's why it's absolutely crucial to continually assess the nutrition standards and incorporate gold standard science to ensure we are providing the safest, most effective nutrition possible.' Related Stories 4/28/2025 3/19/2025 The Federal Food, Drug, and Cosmetic Act The law also says that the nutrients shall be reviewed every four years by the health secretary 'as appropriate.' During such a review, 'the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards,' the law states. 'The Secretary may revise the list of nutrients and the required level for any nutrient required by the table.' Researchers have The FDA's review is part of what officials are calling 'Operation Stork Speed,' an effort Abbott Nutrition and Reckitt Benckiser-Mead Johnson produce just under 80 percent of the infant formula in the United States as of 2019, according to Euromonitor Passport data. The companies did not respond to requests for comment by publication time. Perrigo, another major manufacturer, referred an inquiry to the Infant Nutrition Council of America (INCA). 'INCA members use safe, high-quality ingredients that are scientifically proven to provide the nutrients needed to support healthy infant growth and development—and industry stays dedicated to following the latest developments in health science and clinical research to support healthy infant growth and development,' a spokesperson for the council told The Epoch Times in an email. 'INCA members remain committed to working with HHS and the FDA on Operation Stork Speed to ensure domestic infant formula products continue to meet the highest standards for nutrition and safety, and today infant formula products undergo extensive research, stringent testing, and strict regulatory approval prior to going to market.'
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Miami Herald
09-05-2025
- Health
- Miami Herald
Doctor's illegal butt enhancements in FL left patients feeling burning, feds say
A doctor promised that silicone injections he used for butt enhancements were 'safe' — but many of his patients had bad reactions, including some who went to other doctors to have the silicone removed, according to federal court filings. Now, Nhan Pham, 54, of Orlando, is facing up to three years in prison, according to a May 8 news release from the U.S. Attorney's Office for the Middle District of Florida. Pham misled patients when he assured the silicone oil he ordered online and injected into their bodies during gluteal and butt enhancement procedures was ''natural,' and would dissolve over time,' federal prosecutors said. Some patients felt 'severe pain' as well as burning, discoloration, itchiness, soreness and hardness at their injection sites after receiving injections from Pham at his office in Kissimmee and his Orlando home between 2015 and 2019, according to prosecutors. Silicone injections for body enhancements are not only dangerous, but they're illegal, according to the U.S. Food and Drug Administration. Pham, who's accused of violating the Federal Food, Drug, and Cosmetic Act, has pleaded guilty to a federal charge: receipt in interstate commerce and proffered delivery of an adulterated device, the U.S. Attorney's Office said. His defense attorney, Fritz J. Scheller, told McClatchy News on May 8 that while Pham 'has accepted responsibility for his actions, they should not be the sole measure of the man.' Pham served in the U.S. military and 'has provided exemplary service to this country' and 'to a countless number of his patients,' Scheller said. He added that several patients have expressed support for Pham. For butt enhancement procedures, Pham had patients pay him in cash, according to court documents. He was paid $20,400 in total by six people who received silicone oil injections, prosecutors said. Injections offered to undercover agent The gallons of unapproved silicone Pham ordered online was linked to a U.S. subsidiary of a company located in Japan, according to prosecutors, who said the oil wasn't 'medical grade.' Pham got the silicone oil from an online shop, which 'sourced' the oil from another company, which sourced the silicone from the Japan-based company, prosecutors wrote in filings. Pham was implicated in the criminal case after prosecutors said he offered injections to an undercover agent in September 2019. His sentencing hearing is scheduled for Aug. 14, according to the U.S. Attorney's Office. In the four years that Pham performed the illegal butt enhancement procedures, according to prosecutors, the FDA warned the public about injectable silicone. In a 2017 alert, the agency said unregulated silicone products used for butt, breast and other body enhancements could result in 'serious injuries and disfigurement.' In the U.S., silicone injections are only allowed to be used during eye surgeries, specifically retinal detachment procedures, according to ScienceDirect.
Yahoo
08-05-2025
- Health
- Yahoo
Orlando physician pleads guilty to using illegal silicone in cosmetic surgeries
A doctor in Orlando has pleaded guilty to federal charges over using illegal materials for cosmetic procedures. The Justice Department says Nhan Pham,54, pleaded guilty to receipt in interstate commerce and proffered delivery of an adulterated device. This violates the Federal Food, Drug, and Cosmetic Act. A sentencing hearing is set for Aug. 14. Pham faces a maximum penalty of three years in federal prison. Pham is a physician who performed various cosmetic surgical and nonsurgical procedures. According to the plea agreement, between 2015 and 2019, he ordered silicone oil online and injected that silicone into his patients for gluteal and buttock enhancement procedures at his office and home. The Justice Department states that the 'U.S. Food and Drug Administration has not approved the use of injectable silicone for body contouring or enhancement and has issued warnings to the public advising them of the illegality of and health risks associated with silicone injections.' Prosecutors say Pham inaccurately represented the substance he was injecting into patient's bodies was 'safe,' 'natural' and would dissolve over time. After receiving the silicone oil injections, prosecutors say patients experienced complications that included sharp and severe pain, discomfort, discoloration, itchiness, burning, inflammation, soreness and hardness in the injection areas. On Sept. 24, 2019, Pham offered to perform silicone oil injections on an undercover law enforcement agent. Click here to download our free news, weather and smart TV apps. And click here to stream Channel 9 Eyewitness News live.
Yahoo
29-04-2025
- Yahoo
U.S. Customs seizes counterfeit cigarettes worth $729,000 in Texas
April 29 (UPI) -- U.S. Customs and Border Protection has busted a shipment of fake brand cigarettes worth more than $729,000. CBP officers placed the shipment from Vietnam on hold when it arrived in the United States at Miami Seaport, before intercepting it Friday in Laredo, Texas. Import specialists with the Agriculture Center for Excellence and Expertise found 17,500 cigarette cartons had counterfeit marks. "Our CBP officers and import specialists continue to maintain their vigilance and exercise due diligence to ensure that fake goods do not enter U.S. commerce," said Port Director Albert Flores, Laredo Port of Entry. "They utilize their training, experience and information from the registered trademark owners to authenticate imported merchandise and when they encounter counterfeits to promptly detain and seize such items, thereby protecting the U.S. economy and the consumer," Flores added. Had the cigarettes been sold as "genuine," the shipment would have been worth $729,400, according to CBP officers. "CBP has the authority to detain, seize, forfeit and ultimately destroy imported merchandise if it bears an infringing trademark or copyright that has been registered with the U.S. Patent and Trademark Office or the U.S. Copyright Office," U.S. Customs and Border Protection said Tuesday in a statement. "Trade in counterfeit and pirated goods threatens America's innovation economy, the competitiveness of our businesses, the livelihoods of U.S. workers, and, in some cases, national security and the health and safety of consumers." Last year, CBP officers in Chicago made 121 seizures, containing more than 3.2 million banned Electronic Nicotine Delivery Systems and worth more than $81.5 million. Most of the shipments to the United States came from China with unauthorized trademarks, which violated the FDA's Federal Food, Drug and Cosmetic Act. In October, a Chinese national was extradited from Australia to the United States to face charges related to North Korea's counterfeit cigarette enterprise that reportedly funds its nuclear and weapons of mass destruction programs.
Associated Press
06-04-2025
- Business
- Associated Press
NYXH Investors Have Opportunity to Join Nyxoah S.A. Fraud Investigation with the Schall Law Firm
The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Nyxoah S.A. ('Nyxoah' or 'the Company') (NASDAQ: NYXH) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Nyxoah issues a press release on March 25, 2025, 'announcing that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system', adding that the letter 'means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations … and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review.' Analyst noted that the Company's announcement will likely result in a delay in Genio's commercial launch. Based on this news, shares of Nyxoah fell by more than 21.3% on the next day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. Brian Schall, Esq. 310-301-3335 SOURCE: The Schall Law Firm Copyright Business Wire 2025. PUB: 04/05/2025 07:48 PM/DISC: 04/05/2025 07:47 PM
